The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Code Ac: Attenuation Correction System For Dual-head Variable-angle Gamma Camera With Coincidence Option (code).
Device ID | K994167 |
510k Number | K994167 |
Device Name: | CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) |
Classification | System, Tomography, Computed, Emission |
Applicant | GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel, IL 30200 |
Contact | Dan Laor |
Correspondent | Dan Laor GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel, IL 30200 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-09 |
Decision Date | 2000-03-07 |
Summary: | summary |